FDA Accepts Biogen Idec's Biologics License Application for First Long-Lasting Factor IX Therapy for Hemophilia B07:30 EST Monday, March 04, 2013
WESTON, Mass. (Business Wire) -- Biogen Idec (NASDAQ: BIIB) announced today that the U.S. Food and Drug
Administration (FDA) has accepted the company's Biologics License
Application (BLA) for the marketing approval of recombinant factor IX Fc
fusion protein (rFIXFc) for the treatment of hemophilia B and granted
the company a standard review timeline. Recombinant FIXFc is the first
product candidate in a new class of long-lasting clotting factor
therapies being developed with the goal of reducing the burden of
treatment for hemophilia B.
“We are encouraged by the FDA's acceptance of our application, as we
believe rFIXFc has the potential to transform the care of hemophilia B
by allowing for less frequent injections and helping patients to
maintain low annualized bleeding rates,” said Glenn Pierce, M.D., Ph.D.,
senior vice president of Global Medical Affairs and chief medical
officer of Biogen Idec's hemophilia therapeutic area. “We are working
with the FDA to bring the first major treatment advance for the
hemophilia B community in 15 years.”
The regulatory submission was based on results from B-LONG, the largest
registrational phase 3 clinical study in hemophilia B to date. The study
showed that rFIXFc provides long-lasting protection from bleeding with
fewer injections than are required with the current standard of care.
The company's BLA submission for rFVIIIFc for use in patients with
hemophilia A is on track for filing during the first half of 2013.
About the Fc Fusion Technology Platform
rFIXFc is a clotting factor developed using Biogen Idec's novel and
proprietary monomeric Fc fusion technology, which makes use of a
naturally occurring pathway that delays the destruction of factor and
cycles it back into the bloodstream, resulting in a longer circulating
half-life.
With this technology, rFIXFc is designed to provide long-lasting
protection from bleeding and reduce the treatment burden associated with
hemophilia B, which currently can require more than 100 injections
annually for prophylaxis with commercially-available factor IX products.
Fc fusion technology is used in seven FDA-approved products for the
long-term treatment of chronic diseases including rheumatoid arthritis,
psoriasis and platelet disorders.
About Hemophilia B
Hemophilia B is a rare, inherited disorder in which the ability of a
person's blood to clot is impaired. Hemophilia B occurs in about one in
25,000 male births annually and is caused by having substantially
reduced or no factor IX activity, which is needed for normal blood
clotting. People with hemophilia B therefore need injections of factor
IX to restore the coagulation process and prevent frequent bleeds that
could otherwise lead to pain, irreversible joint damage and
life-threatening hemorrhages. The Medical and Scientific Advisory
Council of the National Hemophilia Foundation recommends prophylaxis as
the optimal therapy for people with severe hemophilia B. Currently,
prophylaxis in hemophilia B typically requires injections up to three
times per week to maintain a sufficient circulating level of clotting
factor.
About the Biogen Idec and Sobi Collaboration
Biogen Idec and Swedish Orphan Biovitrum (Sobi) are partners in the
development and commercialization of rFIXFc in hemophilia B and rFVIIIFc
in hemophilia A. Biogen Idec leads development, has manufacturing
rights, and has commercialization rights in North America and all other
regions excluding the Sobi territory. Sobi has the right to opt in to
assume final development and commercialization in Europe including
Russia, the Middle East and Northern Africa.
About Biogen Idec
Through cutting-edge science and medicine, Biogen Idec discovers,
develops and delivers to patients worldwide innovative therapies for the
treatment of neurodegenerative diseases, hemophilia and autoimmune
disorders. Founded in 1978, Biogen Idec is the world's oldest
independent biotechnology company. Patients worldwide benefit from its
leading multiple sclerosis therapies, and the company generates more
than $5 billion in annual revenues. For product labeling, press releases
and additional information about the company, please visit www.biogenidec.com.
Safe Harbor
This press release contains forward-looking statements, including
statements about the commercialization and impact of long-lasting
hemophilia therapies and regulatory filings. These statements may be
identified by words such as "believe," "expect," "may," "plan,"
"potential," "will" and similar expressions, and are based on our
current beliefs and expectations. Drug development and commercialization
involve a high degree of risk. Factors which could cause actual results
to differ materially from our current expectations include the risk that
unexpected concerns may arise from additional data or analysis,
regulatory authorities may require additional information or further
studies, or may fail to approve or may delay approval of our drug
candidates, or we may encounter other unexpected hurdles. For more
detailed information on the risks and uncertainties associated with our
drug development and commercialization activities, please review the
Risk Factors section of our most recent annual or quarterly report filed
with the Securities and Exchange Commission. Any forward-looking
statements speak only as of the date of this press release and we assume
no obligation to update any forward-looking statements, whether as a
result of new information, future events or otherwise.
Biogen Idec Media Contact:Banks Willis, +1-781-464-3260Public
AffairsorBiogen Idec Investor Relations Contact:Kia
Khaleghpour, +1-781-464-2442Director, Investor Relations

Restrictions

All rights reserved. Republication or redistribution of Thomson Reuters content, including by framing or similar means, is prohibited without the prior written consent of Thomson Reuters. Thomson Reuters is not liable for any errors or delays in Thomson Reuters content, or for any actions taken in reliance on such content. ‘Thomson Reuters’ and the Thomson Reuters logo are trademarks of Thomson Reuters and its affiliated companies.